DNA Vaccines 2011 - Talk by Rick Hancock
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Commercializing DNA vaccines presents several challenges at each phase of development. Early phases require formulations with short term stability and minimal manufacturing requirements. Later phases focus on establishing robust formulations through stability studies, optimizing and validating manufacturing processes, and selecting a final commercial container. Key formulation challenges include achieving room temperature stability while minimizing DNA degradation and particles. Buffers like TE buffer with ethanol addition can enhance plasmid stability, as demonstrated through accelerated stability studies. Final container selection requires consideration of DNA's affinity for glass and potential for metal ion leaching. Cold chain management is also a challenge, making lyophilization or liquid ambient temperature distribution desirable objectives.
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Prof. Dr. Mäder focus on how to select the appropriate PLA/PLGA polymer for small drug molecule applications. He will provide an overview of drug delivery systems, most important formulation techniques and appropriate characterization methods along with application examples.
Alternative polymer systems are required for peptide and protein controlled-release formulations. Dr. Rob Steendam introduces InnoCore´s SynBioSys® biodegradable polymer system demonstrating excellent safety, control over release kinetics and effective preservation of structural integrity and bioactivity of biologics. InnoCore Pharmaceuticals and SynBioSys® multi-block polymer introduction, challenges in development of controlled-release formulations of biological therapeutics including various examples and development and cGMP manufacturing at InnoCore are key elements of his presentation.
In this webinar, you will learn:
• drug delivery systems
• most important formulation techniques
• appropriate characterization methods along with application examples
ICH
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Optimisation of industrial process
This document outlines a lecture on optimizing organic reactions and processes. It discusses various techniques for selecting appropriate synthetic routes and scale-up methods, including choosing raw materials and reagents. It covers quality control aspects, health and safety considerations like material safety data sheets, and environmental impacts of API manufacturing. The lecture aims to provide an introduction to optimization as well as approaches for selection of synthetic routes, process variables, in-process controls, work-up and isolation of products, and planning for scale-up.
Key Considerations in Stability Studies for Biopharmaceuticals
Conducting stability studies in accordance with regulatory requirements requires technical expertise, established infrastructure and compliant facilities. There are multiple contractors available to offer these services and often the selection of a lead contractor is based on top level quotes and business development feedback. However, based on such selection strategies, once the studies are established at a contract site, additional factors may arise that further impact the overall costs and timelines for your project. These include hidden costs due to factors such as data mining, trending and investigations required during an established study.
Factors that affect timelines include flexibility required to ensure relevant data is available as required for key submission dates. If this is not the case, this will result in reduced shelf life assignment and may have a direct impact on product development timeline.
This talk will look at key points to consider in the selection process and provide tools to aid in selection of a lead contractor.
Ich guidelines
This document discusses guidelines for stability testing of pharmaceuticals according to the International Conference on Harmonization (ICH). It describes the ICH guidelines for stability testing, including stability protocols, reports, and studies. The key points covered include stability testing procedures, factors affecting drug stability, types of stability studies, and organizations that regulate stability guidelines such as the ICH.
Ds cto optimizeantibodymanuf
This document summarizes the use of differential scanning calorimetry (DSC) to optimize an antibody manufacturing process. DSC was used to screen conditions for a viral inactivation step and identify increased pH storage conditions for maximum stability. Low pH treatment reduced thermal stability, indicating structure loss. DSC provided insights into instability causes and process improvements, demonstrating its role in biotherapeutic development.
Designing of drug delivery system for biotechnology products considering stab...
"Where there is life, there is DNA, where there is DNA, there is biotechnology." Biotechnology, as the word suggests, is combination of biology and technology. So the importance of biotechnology and biotechnology products in our life is increasing day by day. That's why we have to produce biotechnology products in a safer manner and also maintain that through it's shelf-life.We have also research on improving methods of improving it's stability. In this topic, I also tried to discuss bioinformatic-driven strategies that are used to predict structural changes that can be applied to wild type proteins in order to produce more stable variants. The most commonly employed techniques PEGylation, stochastic approaches, empirical or systematic rational design strategies.
Drug delivery system for biotech product considering stability aspects and mo...
Drug delivery system for biotech product considering stability aspects and mo...zobaida mostarin nishi
Drug delivery is becoming a whole interdisciplinary and
an independent field of research and is gaining the attention of
pharmaceutical makers, medical doctors, and industry. A
targeted and safe drug delivery could improve the performance
of some classical medicines already on the market and,
moreover, will have implications for the development and
the success of new therapeutic strategies, such as peptide and
protein delivery, glycoprotein administration, gene therapy and
RNA interference.Hot melt extrusion with PVA – solubility enhancement, supersaturation perform...
Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs).
In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development.
A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations.
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In this webinar, you will learn:
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Hot melt extrusion with PVA – solubility enhancement, supersaturation perform...
Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs).
In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development.
A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations.
This webinar includes:
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- Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options
- Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions
In this webinar, you will learn:
- which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA)
- why PVA is more than just a polymer
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Regulated mycotoxin uplc agilent
This document discusses a stable isotope dilution assay (SIDA) method for the accurate quantitation of 11 regulated mycotoxins in solid food matrices using LC-MS/MS. A universal extraction procedure is used to extract the mycotoxins from maize samples along with 13C-labeled internal standards. The extracts are then analyzed by UHPLC-MS/MS on an Agilent 6490 triple quadrupole mass spectrometer using multiple reaction monitoring for sensitive detection and quantification of the mycotoxins at levels required to enforce EU regulations. Validation of the SIDA method showed it provides accurate quantitation of regulated mycotoxins in maize while being cost-effective and easy to implement.
Pre HMW PE Trial
this is one example of my job presentation as a plant trial leader in developing HMW-PE using Chromium Catalyst
BADG_0215_Ritter_Slides.pptx
The document discusses the analytical requirements for biotechnology and biosimilar products. It notes that biologics have different CMC requirements than traditional small molecule drugs due to significant differences in their raw materials, production processes, physiochemical properties, and other factors. These differences make biologics more complex and risky than traditional drugs. The key regulatory documents that provide guidance on CMC analytical requirements for biologics are identified as FDA regulations, ICH guidelines, and the ICH Common Technical Document, which provides a standardized format for data presentation. Critical elements for establishing reliable product specifications are said to be the capabilities of the manufacturing process, product stability, clinical batches, and analytical method capabilities. A variety of analytical technologies are described that are
Downstream processing
This document discusses downstream processing in biotechnology. It defines downstream processing as the steps occurring after fermentation to recover and purify products. The key unit operations in downstream processing include cell removal, concentration, and purification techniques like chromatography. The level of purification required depends on the intended use and market for the product. Common downstream processing techniques are outlined along with considerations for designing efficient bioseparation processes.
Drug excipient Compatibility
Drug-excipient compatibility studies are important to identify compatible excipients for drug formulations. Compatibility can be tested using various analytical techniques including thermal methods like DSC and DTA, accelerated stability studies, spectroscopy like FTIR, and chromatography like TLC. Incompatibilities are identified by changes in thermal behavior, degradation of the drug, or appearance of new peaks in analytical tests. Common techniques involve storing drug-excipient mixtures under accelerated conditions and monitoring the samples for physical or chemical changes over time. The results of compatibility studies provide critical information for formulation development and regulatory filings.
SO (7 - 2 B) Terminal Sterlization Qualifications, Process & Highlights
The document discusses the key elements required for terminal sterilization qualification including:
1) Description of the sterilization process, parameters like temperature and time, and loading patterns.
2) Studies demonstrating heat distribution and efficacy like biological indicators.
3) Specifications for controlling the process and ensuring sterility of the product and packaging.
4) Procedures for monitoring the sterilization environment and packaging integrity.
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Diteba Research Laboratories Corporate Capabilities
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Polymer based drug delivery systems for parenteral controlled release: from s...
Polymer based drug delivery systems for parenteral controlled release: from s...
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Key Considerations in Stability Studies for Biopharmaceuticals
Key Considerations in Stability Studies for Biopharmaceuticals
Designing of drug delivery system for biotechnology products considering stab...
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SO (7 - 2 B) Terminal Sterlization Qualifications, Process & Highlights
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DNA Vaccines 2011 - Talk by Rick Hancock
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